An interventional study of sleeve gastrectomy and sleeve gastrectomy with omentopexy in Obesity, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Treatment
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.
This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.
Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).
The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 526 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
OR initial BMI ≥ 40 Kg/m².
Exclusion Criteria:
realization of a sleeve gastrectomy alone
Procedure: sleeve gastrectomy
realization of a sleeve gastrectomy followed by an omentopexy
Procedure: sleeve gastrectomy with omentopexy
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature
Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone
Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
Time frame: 2 years postoperatively
Plan to share: No
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Centre Hospitalier Departemental Vendee